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FDA 510(k)

SEA2 SELF ETCH ADHESIVE

K-Number: K070956 · 2007-05-22

Applicant3M Espe Dental Products
Decision Date2007-05-22
Product CodeKLE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SEA2 SELF ETCH ADHESIVE is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K070956. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEA2 SELF ETCH ADHESIVE?

SEA2 SELF ETCH ADHESIVE is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is 3M Espe Dental Products. The 510(k) number is K070956.

When did SEA2 SELF ETCH ADHESIVE receive FDA 510(k) clearance?

SEA2 SELF ETCH ADHESIVE received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070956.

Who is the listed applicant for SEA2 SELF ETCH ADHESIVE?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEA2 SELF ETCH ADHESIVE?

The FDA product code for SEA2 SELF ETCH ADHESIVE is KLE.

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Other records listing 3M Espe Dental Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KLE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262252MPa Max adhesiveDen-Mat Holdings, LLCK260485Any-EtchMediclus Co., Ltd.K260430Porcelain Etch GelBelport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ Universal AdhesivePremier Dental Products CompanyK251587VITA VMLC PrimerVita Zahnfabrik H. Rauter GmbH & Co. Kg.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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